Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-70
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are:
1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 30-70 years
Body Mass Index (BMI) of 27.5-40kg/m²
Disqualifiers
Subjects with history of osteoporosis or proliferative diabetic retinopathy
Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
Patients with symptomatic coronary artery disease.
Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication).
Trial design
Design model
Parallel
Treatments tested in this trial
Pioglitazone
DrugParticipants will be taking Pioglitazone tablets 1/day for 24 weeks.
Placebo
DrugPlacebo for Pioglitazone
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Pioglitazone Administration GroupActive comparator 1 intervention
Group B: Placebo/Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Systolic function
Measurement of change in systolic function of the heart using cardiac MRI
Time frame
Baseline and 6-months post treatment (approximately 24 weeks)2
Change in Diastolic function
Measurement of change in diastolic function of the heart using cardiac MRI
Time frame
Baseline and 6-months post treatment (approximately 24 weeks)Secondary outcomes
1
Myocardial insulin sensitivity
Measurement of change in Free Plasma Glucose (FPG) in blood plasma
Time frame
Baseline and 6-months post treatment (approximately 24 weeks)2
Myocardial fat content
Measurement of change in myocardial fat content
Time frame
Baseline and 6-months post treatment (approximately 24 weeks)3
PCr:ATP ratio
Measurement of change in PCr:ATP ratio
Time frame
Baseline and 6-months post treatment (approximately 24 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov